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History of Changes for Study: NCT03981484
REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy (REPLaCE)
Latest version (submitted June 7, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 7, 2019 None (earliest Version on record)
Comparison Format:
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Study NCT03981484
Submitted Date:  June 7, 2019 (v1)
Open or close this module Study Identification
Unique Protocol ID: 00001
Brief Title: REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy (REPLaCE)
Official Title: REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2019
Overall Status: Unknown status [Previously: Not yet recruiting]
Study Start: January 2020
Primary Completion: October 2022 [Anticipated]
Study Completion: January 2023 [Anticipated]
First Submitted: June 6, 2019
First Submitted that
Met QC Criteria:		 June 7, 2019
First Posted: June 10, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:		 June 7, 2019
Last Update Posted: June 10, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Bellal A. Joseph, MD, FACS
Responsible Party: Sponsor-Investigator
Investigator: Bellal A. Joseph, MD, FACS
Official Title: Chief of the Division of Trauma, Acute Care, Burn, and Emergency Surgery
Affiliation: University of Arizona
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option. This phase II clinical trial evaluates the use of 4-Factor PCC in addition to standard resuscitation methods compared to standard resuscitation methods alone in patients with TIC. Patients will be randomized at a 1:1 ratio. The primary endpoint of this trial will be 30 day mortality.
Detailed Description:
Open or close this module Conditions
Conditions: Coagulopathy
Hemorrhage
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 280 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PCC
single dose of 4-Factor PCC in addition to standard resuscitation methods
 Biological: Prothrombin Complex Concentrate
single dose of 25 IU/kg of 4-PCC at time of enrollment
Active Comparator: Standard of Care
standard resuscitation methods only
 Biological: Whole Blood, Plasma, Packed Red Blood Cells
site's standard resuscitation protocol
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 24 Hour Mortality
[ Time Frame: 24 hours after enrollment ]

Assess if patient is alive at 24 hours post treatment
Open or close this module Eligibility
Minimum Age: 15 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. ≥15 years old
  2. anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score ≥ 2

Exclusion Criteria:

  1. Cardiopulmonary Resuscitation > 5 minutes
  2. Penetrating cranial injury or exposed brain matter
  3. Anticoagulation treatment
  4. Transfer patients
  5. Known pregnancy
  6. Prisoners
Open or close this module Contacts/Locations
Study Officials: Bellal Joseph, MD
Principal Investigator
University of Arizona
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services